Safety Report: MKS Enterprise LLC Honey - recalled due to undeclared active pharmaceutical ingredient tadalafil, USA

United States

This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. Tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction (ED). Product was sold through our website, wholesaleonline1.com Mar 2022 to July 2022 and ­ distributed in any US State. To date, wholesaleonline1.comhas not received any reports of adverse events related to this recall.

The product comes in a black box and contains 12 sachets of 15 grams of honey with different expiration dates stamped on the back side. This undeclared ingredient (tadalafil) may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil. Consumers who have purchased Vital Honey on wholesaleonline1.com are urged to immediately discontinue use and return the recalled product for a full refund.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: MKS Enterprise LLC
Brand name: Dose Vital
Product recalled: Honey
Reason of the recall: Undeclared active pharmaceutical ingredient tadalafil
FDA Recall date: July 19, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mks-enterprise-llc-voluntary-recalls-dose-vital-vip-vital-honey-due-presence-undeclared-tadalafil